Laboratory self-calibration procedures for the preparation of the basic requirements 1, Overview Overview part of the main brief description of the use of the inspected measuring instruments, principles and structure (including the necessary structural schematic). If the principle of the inspected measuring instruments and the construction of the relatively simple, that is not necessary to introduce and explain the content of the part can be omitted. 2, technical requirements should focus on the technical requirements and the measurement of the inspected measuring instruments and performance, service life and use of safety-related content, which are generally: 2.1 accuracy level (such as no level can be omitted) 2.2 measurement performance, such as accuracy, sensitivity, stability, etc. 2.3 physical (or), physical and chemical properties, and the use of the measurement instruments. 2.3 physical (or mechanical) properties, such as density, viscosity, strength, hardness, strong unity, resistance to friction, corrosion resistance, resistance to interference, etc. 2.4 safety and reliability, such as insulation strength, sealing performance, sealing requirements and other safety measures. 2.5 Appearance of the quality requirements, such as roughness of the edges, the clarity of the scale, as well as on the requirements of scratches, bruises, burrs, cracks, bubbles and other aspects of the requirements. 2.6 Other relevant requirements for the use of 3, the calibration project calibration project refers to the inspected parts of the inspected measuring instruments and content. Determine the calibration project to start from the actual need, clear and reasonable, practical. Among them, in accordance with the specific circumstances, some measuring instruments in use and repair of the calibration project, can be different from the new manufacture of the calibration project. 4, the specific calibration method specific calibration method is the measurement of measuring instruments inspected by the calibration of the project specified in the specific operation methods and steps. Specific methods and steps to be clear, specific and practical. Calibration of all formulas and formulas used in the constants and coefficients must have a reliable basis. 5, the results of the calibration of the results of the calibration of the results of the test refers to the end of the calibration of the measurement of the instrument is qualified or applicability of the conclusions made by the school. Measuring instruments must be self-certified before use. Calibration failed, may not be used. 6, self-calibration cycle self-calibration cycle refers to the inspected measuring instruments between two adjacent calibration interval. The length of the calibration cycle should be based on the measured performance of the inspected measuring instruments, the use of environmental conditions and frequency and other factors to determine. Generally should be based on the use of the unit to determine the longest cycle.7, appendices and additional instructions according to the needs of measuring instruments calibration, appendix can include the following parts: 7.1 additional description of the technical content 7.2 a variety of special calibration devices or tools related to the graphics or instructions 7.3 calibration record forms and other document formats 7.4 a variety of graduated tables, calculation tables and parameter tables 7.5 calibration data processing (including) Numerical Modification) and Calculation Examples7.6 Other Relevant Technical Contents7.7 Name of the Draftsman and Name of the Approver
Management Provisions on Storage and Use of Laboratory Chemicals and Microbiological Media
Measurement Scope of MeasurementName of the Measurement Instrument and Equipment No. Test Procedure Test UnitTraceability to the Compulsory Test Mechanical Mass BalanceJJG156-1983Measurement and Certification Testing Institutions national benchmark Y quality glass gauge JJG196-1990Y pressure gauge JJG573-188Y temperature measuring element thermometer JJG161-1994Y thermodynamic temperature high-temperature furnace JJG75-1995Y oven, drying oven, incubator JJG75-1995Y chemical quality gas chromatograph JJG700-1999 metrological calibration and testing institutions National standard substances Y liquid chromatograph JJG705-1990Y gas chromatograph-mass spectrometer N liquid chromatograph-mass spectrometer N thin-layer chromatograph N mass spectrophotometer JJG178-1996 measurement calibration and testing organizations National benchmark Y atomic fluorescence spectrophotometer JJG682-1990N ultraviolet-visible spectrophotometer JJG689-1990 measurement calibration and testing organizations National Reference Y Atomic Absorption Spectrophotometer JJG594-1990Y Rotameter JJG536-1998Y Inductively Coupled Plasma Mass Spectrometer Calibration and Testing Center for National Standard SubstancesN
Management Regulations on Storage and Use of Laboratory Chemicals and Microbiological Mediums
Regulations on Disposal of SamplesThese regulations cover the categorization of stored samples, definition, duration and quantity of samples, preservation, and disposal of samples, including the classification of stored samples, preserved samples, and the use of samples. Definition, preservation period and quantity, sample transportation and storage conditions.1, the classification of preserved samples room temperature preserved samples: refers to the need for room temperature (15 ~ 25 ℃), in the preservation period of the nature of the sample is more stable, not easy to corruption and deterioration; or refers to some test items will not change the sample. Refrigerated preserved samples: refers to samples that need to be preserved at 0-4℃ and cannot be frozen. Frozen preserved samples: refers to samples that have been frozen and processed and need to be preserved at low temperatures (below -18℃).2. Definition of preserved samples refers to samples whose properties, in whole or in part, do not change over time during the preservation period of the samples.3. Sample Preservation Period and Quantity of Samples Samples are preserved for 2 months (except for samples for testing bacteria). Controversial or other requirements of the sample preservation period can be appropriately extended. The weight of each preserved sample shall be not less than the amount required for the second test.4. Sample transportation and storage conditions5. Handling of special samplesIf samples with pathogenic bacteria are found during the test work, they shall be autoclaved in time. Other special samples, such as puffer fish, shellfish toxins exceeding the standard bivalve shellfish, etc., should choose a fixed place of deep burial or incineration.
Laboratory chemicals, microbial media storage, use and other aspects of management regulations
Sample room duties I. Reception of door-to-door work of the masses enthusiastic, civilized language, courteous. Two. Responsible for negotiation with customers, product testing methods, judgment basis, licensing time limit, evidence collection methods and other matters, and to assist customers to fill out the commission in detail. Three. Receive samples of the following points must be clear and unambiguous, sample properties, test content and methods, product testing and judgment based on the time limit for the certificate, the amount of testing services, the report to take the way, the way the samples are disposed of, the commissioner's contact address and phone number. IV. Sample acceptance, responsible for sample management procedures in accordance with the registration number, the sample is issued in a timely manner so that the test as soon as possible. V. Sample items in a timely manner to fill out the registration form, according to the type and storage conditions for storage, stacked neatly, clearly marked, perishable samples should be special storage. According to certain procedures and formalities to deal with more than the retention period samples. Six. Upon receipt of the test report, timely evaluation, careful and meticulous checking of the test report, such as the bottom of the test data, print in a timely manner, print and hand over to the person in charge of quality checking signature, seal. Report in duplicate, one including the original material of each section of the bound book and archives, a registration issued to the commissioning unit. VII. Do a good job of confidentiality, print the report of the computer to be encrypted, print the material shall not be lent at will, other staff and customers are not allowed to look through the material at will. Eight. Responsible for the safety of the sample room, health and cleanliness, often record the conditions of sample storage. Nine. Often seek the views of customers, collect and summarize customer feedback and suggestions. Ten. Minors please do not enter.
Laboratory chemicals, microbial media storage, use and other aspects of management regulations
Reagent warehouse management regulations I. Reagents should be purchased application, and the establishment of the consumption and consumption of reagents. Reagents should be purchased application, and the establishment of the consumption of consumption registration. Two. Procurement of hazardous materials must be designated to familiar with the business of the person in charge. Three. Poisonous drugs stored in the safe, warehousing and storage of dangerous goods should be strictly enforced "five double" system (two-man tube, two-man hair, two-man transport, two locks, two people with). Four. Treasury and warehouse should be kept clean and tidy on a regular basis, fireworks are strictly prohibited, no one is allowed to enter. V. Reagents in the library should be scientifically categorized storage. Six. Reagents should follow the implementation of the first-in, first-out principle.
Help: laboratory chemicals, microbial media storage, use and other aspects of management
Bacteria (poisonous) species management system 1. Bacteria (poisonous) species should be responsible for the custody of the person in charge of, stored in a safe place, double lock. Storage conditions 4-10 degrees. Work transfer should be a comprehensive handover. 2. preservation of bacteria (poisonous) species should be regularly transferred within the specified time (6 months), the transfer of seeds should be carried out in the aseptic room or inoculation hood to prevent contamination. 3. preservation of bacteria (poisonous) species shall have a detailed registration, including the species number, source, name, type, isolation period, the record of the transmission, etc. 4. bacteria (poisonous) species in the custody of the process of bacteria mutation or death should be documented in the archives and reported to the head of the department. Record, and report to the head of the department. 5, one or two types of bacteria (venom) species to receive the use, there should be two people to participate in accordance with the relevant provisions of the process. For work needs to use three, four types of strains, must be custody of the head of the department agreed. Outside units need to use strains, all with a letter of introduction approved by the leadership of the center before receiving. One or two types of bacteria (viruses) are not allowed to be issued to outside units.6. The scope of preservation, transfer, destruction of bacteria (viruses) shall be strictly in accordance with the relevant provisions of the Ministry of Health.7. All bacteria (viruses) shall be sent to a person to receive, and shall not be mailed.8. Without approval, individuals shall not be work, international and domestic exchanges of all types of strains of bacteria (viruses).9. Chemicals, microbial media storage, use and other aspects of management regulations
Clean room management regulations, a summary: the laboratory is a closed laboratory, the use of the blower to send in fresh air through the initial filtration, intermediate filtration and ultraviolet sterilization measures to achieve the clean and sterile purpose. Indoor up to 10,000 levels, the work surface up to 100 levels of cleanliness. It is specially designed for the use of aseptic test or experiments that need to be clean. Second, the operating procedures: 1, 1h before the experiment to open the air filtration and air conditioning coefficients, with disinfectant solution to disinfect the workbench and experimental equipment, 0.5h before the experiment to open the ultraviolet lamp disinfection. 2, clean room staff hand disinfection with iodophor immersion for 5min, indoor disinfection with 0.5% peroxide acetic acid. 3, into the clean room should be sufficiently washed hands before entering the second shift to take off the coat, shoes to enter the second shift to wear a special isolation clothing (pants, masks). Wear special isolation clothes (pants), masks, hats, change into special working shoes, disinfect your hands with disinfectant and dry them. If necessary, wear gloves and rubber shoes. Turn on the wind shower switch into the wind shower room, for 360 ° rotating activities, to be automatically closed after the wind shower, into the clean room to start work. 4, the experimental process, experimental equipment, experimental specimens in and out of the clean room, all through the transfer window. 5, after the experiment, remove all items, disinfectant solution to disinfect the work surface, and then open the air supply, purify the air for 0.5h, and at the same time, turn on the ultraviolet lamp disinfection. 6, It is strictly prohibited to drink, eat, smoke in the clean room, and try not to talk or talk less in the work. It is not allowed to store public and private items in the clean room that have nothing to do with the clean room.7. Waste in the experiment shall be placed in containers and sterilized centrally. The used isolation clothes, shoes and personal protective equipment shall be sterilized before reuse. Third, notes: 1, purification laboratory should be good temperature, humidity records, operating conditions and maintenance records. 2, often keep the clean room clean, cleaning once a month, determination of airborne bacteria once, if necessary, replace the filter membrane, to ensure that the clean function should be achieved. 3, control the number of people entering the clean room, and the experiments have nothing to do with the personnel shall not enter.
Laboratory chemicals, microbiological media storage, use and other aspects of management
Microbiological testing of internal quality control program, content and methods: 1, microbiological testing methods of control microbiological testing methods must be based on the current effective national standards, industry standards and health administrative departments issued by the test method. The use of non-standard methods, must be strictly in accordance with the "procedural documents" in ****/02-07 "testing deviation from the guidelines, procedures or standards (norms) of the exceptions to the licensing requirements". 2, microbiological testing environment control 2.1 Regularly do a good job of laboratory cleanliness and sanitation and disinfection, strict aseptic operation to avoid inter-room contamination and laboratory infections occur. 2.2 Infected items and waste should be in accordance with the The center's "three wastes" disposal system disinfection and sterilization before cleaning or disposal, to prevent environmental pollution. 3, the control of instruments and equipment function operators must strictly comply with the operating procedures, make a good record, and do a good job of running checks and maintenance of the instrument. 4, the quality of the medium to control the use of identification of qualified media is to ensure the quality of microbiological testing an important link. Important link. Where the raw materials prepared or prepared with dry medium culture medium should meet the following general requirements and quality identification requirements. 4.1 purchase of new batches of dry medium, should be known standard strains for quality identification before use. 4.2 preparation of culture medium should be medium preparation records. 4.3 general quality requirements of the medium (1), Appearance: the medium should have a clear labeling and preparation date. Liquid culture medium should be clear. Containing inverted tube, the inverted tube should be full of liquid, no air bubbles; solid culture medium should maintain appropriate hardness, no bacterial droplets before inoculation. (2), PH: from time to time sampling and inspection, required in the provisions of the PH ± 0.2. There are indicators of the culture medium to maintain the color that should appear. (3), the volume of pouring agar plate is generally 15ml, the slant is not more than 2/3.(4), aseptic test: aseptic dispensing medium should be in the incubator (36 ℃) overnight, sterile growth before use, autoclaved medium should be randomly sampled 5-10% for aseptic test. (5), custody: the culture medium should be placed in the appropriate temperature preservation, made of plate culture based on refrigerator preservation. (6) Use: use the medium within the validity period, observe whether the medium deteriorates when using it.4.4 Requirements for quality identification of commonly used medium: use the known characteristics of the stable standard strains of bacteria as the observation of bacterial culture, and observe the state of the indicators of the medium, it is judged to be a qualified medium, and use. Otherwise, it will not be used.5. Quality control of diagnostic serum 5.1 Diagnostic serum must be stored in 4℃ refrigerator, and stored in the refrigerator after use to prevent contamination.5.2 Before use, serum should be examined to see if there is any mold dyeing and bacterial infection, if there is, then it should not be used and attention should be paid to using it within the validity period, if expired serum should be appraised and considered as usable before being permitted to use it.6. Quality control of standard bacterial strains: The management and use of the standard strains should be carried out strictly in accordance with the "Bacterial (Toxin) Species Management System". 7. 7, actively participate in the higher business sector issued by the blind sample assessment that is to carry out inter-laboratory comparison and the quality management office of the center organized by the personnel comparison verification experiments. Second, the assessment and evaluation of the Quality Management Office of the microbiological quality control against the program requirements for inspection and evaluation.
Laboratory chemicals, microbiological media storage, use and other aspects of management regulations
Hygiene Physical and Chemical Inspection internal quality control program Laboratory internal quality control is the process of self-control of the analytical quality of the inspectors, the purpose is mainly to detect certain incidental errors, so that at any time to take the appropriate corrective measures, to ensure that the correctness of the results of the analysis in the laboratory. The purpose is mainly to detect certain incidental errors in time in order to take corrective measures at any time to ensure the correctness of analytical results in the laboratory. According to my center's "Quality Manual" in the quality policy requirements "procedural documents," the provisions of the "Health Physical and Chemical Inspection of internal quality control program" is now developed. First, the content and method 1, the control of testing methods Testing methods must be based on the current valid national standards, industry standards and health administrative departments issued by the test method. The use of non-standard methods, must be strictly in accordance with the "procedural documents" in *****/02-07 "testing work deviates from the guidelines, procedures or standards (norms) of the exceptions to the licensing requirements". 2, the control of the testing environment 2.1 Regularly do a good job of laboratory cleanliness and hygiene, testing the working environment conditions are strictly controlled to meet the requirements of the use of instruments and testing methods specified in the requirements. 2.2 Toxic substances generated in the experimental process, should be in accordance with the Center's "three wastes" disposal system "to prevent pollution of the environment. 3. Control of Instruments, Equipment and Standard Substances 3.1 All instruments and equipment shall be purchased, used, maintained and managed in accordance with the relevant Procedural Documents and Operational Guidelines of the Center. 3.2 The purchase, preparation, management and use of standard substances shall be carried out according to relevant Procedural Documents. 4, sampling quality control According to the characteristics of the samples, select the appropriate sampling instruments (including refrigeration conditions), collect the samples in accordance with the prescribed random sampling method, and the sampling procedures and sample management shall be implemented in accordance with the relevant "Procedural Documents". 5, routine monitoring quality control 5.1 Requirements for each determination of the sample must be blank test, the determination of the batch of samples, a certain number of randomly selected samples for spiked recovery determination. It is generally required that the recovery of water samples reaches 95-105%, and the recovery of samples of food, air and biological materials reaches 85-110%. When the recovery rate is lower than or beyond the above specified range, the reason should be found until the recovery rate meets the above requirements. 5.2 Drawing of standard curve and linearity test: When the analytical method applying the standard curve is used for the first time, a calibration curve can be drawn to ensure its upper and lower limits of detection and the range of determination (linear range). In order to limit the error in the analytical results to the required range, the measurement range can be specified between the lower and upper limits of measurement. In order to improve the accuracy and reliability of the results, it is mandatory that each batch or each determination of the samples be carried out simultaneously with a standard curve. The correlation coefficient r of the standard curve should be greater than or equal to 0.995, otherwise, the reasons affecting the standard curve should be found and may be corrected, re-measurement and drawing a new standard curve. 5.3 Analysis of quality control samples, quality control samples of the matrix should try to detect the chemical composition of the sample matrix and physical properties of the same or similar, its concentration should be within the concentration range of the test sample, quality control samples can be prepared by the unit can also purchase standard substances. Quality control sample pretreatment, measurement method, measurement time must be the same batch with the test sample. If the deviation of the quality control sample is found to be greater than two times the relative standard deviation provided by the measurement method, the measurement should be stopped immediately and measures should be taken. And the last quality control after the measurement of the sample re-measurement. 6, after the analysis of quality control After the determination of the sample, we must check whether the value record is accurate, whether there is any omission, whether there is any error in the calculation, whether the results have been reviewed, whether the report has been signed and so on. For measurement results below the detection limit of the data should be reported less than the lower limit of detection, if the report is not detected, should indicate the lower limit of detection. 7.1 Actively participate in the proficiency testing activities organized by the higher-level business management department and the blind sample assessment issued by the higher-level center, i.e., inter-laboratory comparison. 7.2 Use mathematical and statistical techniques for internal quality control. 7.3 Regularly use certified standard substances for internal quality control. 7.4 Conduct indoor testing personnel comparison. Second, the assessment and evaluation of the Quality Management Office of the Inspection Division to check whether the quality control of basic tests and daily testing work quality control.